Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease

Chronic Liver Disease Clinical Trial

Official title:

Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629603
• Other study ID #: KMUH-IRB-950347
• Status: Completed
• Phase: N/A
• First received: February 26, 2008
• Last updated: April 17, 2013
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: April 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.

Description:

Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with anti-HCV positive

Exclusion Criteria:

• Anti-HCV-negative patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Liver Disease
• Fibrosis
• Liver Diseases

Intervention

Genetic:
• cytokine
polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease
• cytokine polymorphisms
Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis
• cytokine polymorphism
fibrosis-relating cytokine polymorphism

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokine gene polymorphism on disease severity		years	No